Phase 1 N=47 Bioavailability Study of Enoxaparin Sodium Chemi and Clexane s.c.
Enoxaparin Sodium is Administered to Healthy Volunteers
Primary: Cmax (Anti-FXa and Anti-FIIa) — 0.8593; 0.8698; 0.1187; 0.1296 IU/mL
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 1 N=14 A Single-Dose Trial to Examine the Within Subject Variability of Clexane® in Healthy Adults Under Fasting Conditions
Clexane is Administered to Healthy Volunteers
Primary: Anti-FXa Cmax — 0.999; 0.926 IU/mL
Phase 4 N=62 Enoxaparin Dosing in Obesity
Obesity
Primary: Proportion of Patients With an Initial Therapeutic Anti-Xa Level at Steady State in Each Group — 25; 20 Participants
Phase 1 N=62 Phase 1 Study of ELX-02 in Healthy Adult Subjects
Genetic Disease · Nonsense Mutation
Primary: Pharmacokinetic Parameters - Plasma AUC0-24 — 1105.126; 3125.484; 11018.22; 28235.823 ng*h/mL
Phase 1 N=63 A Study of LY2951742 in Healthy Volunteers
Migraines
Primary: Number of Participants With Clinically Significant Effects — 0; 0; 0; 0 participants
N/A N=120 Once Daily Enoxaparin for Outpatient Treatment of Acute DVT and/or Pulmonary Embolism
Deep Vein Thrombosis · Pulmonary Embolism
Primary: Major Bleeding Complication — 0; 3 participants
Phase 2 N=80 Weight-Based Enoxaparin Dosing and Real-Time Dose Adjustment in Orthopaedic Trauma
Venous Thromboembolism · Deep Vein Thrombosis · Pulmonary Embolus
Primary: Number of Participants With Venous Thromboembolism Events — 1 Participants
N/A N=21 Once Weekly Subcutaneous Ports for the Administration of Anticoagulants
Venous Thromboembolism
Primary: Average Subcutaneous Anti-Xa Blood Levels — 1.43 IU/mL
Phase 2 N=107 A Healthy Volunteer Pharmacokinetics (PK)/Pharmacodynamics (PD), Safety and Tolerability Study of Andexanet in Healthy Japanese and Caucasian Subjects
Bleeding
Primary: Percent Change in Anti-Fxa Activity From Baseline to the End of Infusion (EOI) Nadir. — -94.50; -29.00; -98.00; -37.00 percent change — p=0.0275
Phase 1 N=42 A Study of a Single Subcutaneous Dose of ALXN1210 in Healthy Adult Participants
Healthy
Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 19; 11; 5 Participants
Phase 1 N=28 Bioequivalence Study in Healthy Subjects, 2*5 mg Tablets Rivaroxaban Versus 1*10 mg Tablet Rivaroxaban
Therapeutic Equivalency
Primary: Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity After Single Dose (AUC) Incl. Bioequivalence (BE) Evaluation — 1374; 1268 µg*hr/L…
Phase 4 N=28 Study to Evaluate Weight-based Enoxaparin Dosing in Obese Medical Patients at Risk for DVT
Obesity · Venous Thrombosis · Anticoagulants
Primary: Peak Low Molecular Weight Heparin Anti-Xa Activity Level. — 0.25 IU/mL
Phase 1 N=64 Safety and Pharmacokinetics of Single and Multiple Ascending Doses of 3K3A-APC in Healthy Adult Volunteers
Healthy
Primary: Adverse Events That Meet Dose-limiting Toxicity Criteria Specified in Protocol. — 0; 0; 0; 0 participants
Phase 2 N=64 Low Molecular Weight Heparin or no Treatment Following Cesarean Delivery
Thromboembolism
Primary: Rate of Eligible Individuals Enrolled and Retained Through Full Study Procedures — 694; 611; 64; 61 participants
Phase 1 N=16 A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Emicizumab in Healthy Chinese Volunteers
Healthy Volunteers · Hemophilia A
Primary: Maximum Observed Plasma Concentration (Cmax) of Emicizumab — 7.11 microgram per milliliter (μg/mL)
Phase 2 N=215 Factor Xa Inhibitor, PRT054021, Against Enoxaparin for the Prevention of Venous Thromboembolic Events (EXPERT)
Thromboembolism
Primary: Incidence of Adjudicated Venous Thromboembolism (VTE) — 20; 15.4; 10 Percentage of Participants
Phase 1 N=207 Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers
Healthy Male Subjects
Primary: Maximum Observed Drug Concentration (Cmax) of ENZ215 and EU- and US-sourced Prolia® — 7662.99; 7742.64; 8033.14 ng/ml
Phase 1 N=16 A Study of Multiple Doses of ALXN1210 in Healthy Adult Participants
Healthy
Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 6; 6; 4 Participants
Phase 1 N=24 Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers
Anemia
Primary: AUC0-t — 37440.71; 34483.73; 41150.49 mUI*h/mL
Phase 1 N=21 Safety and Tolerability Study of E-WE Thrombin in Healthy Adult Subjects
Thrombosis
Primary: The Number of Subjects With Treatment-emergent Adverse Events (TEAEs) Will be Summarized Using Frequency Counts. — 0; 0; 0; 3 Participants
Phase 1 N=96 Switching Study From Warfarin to Rivaroxaban
Venous Thrombosis
Primary: Emax (Maximum Effect) on Prothrombin Time (PT) (Coagulation Test) — 4.393; 1.884; 1.573 ratio — p=<0.0001
Phase 2 N=110 Enoxaparin Metabolism in Reconstructive Surgery Patients
Venous Thromboembolism · Deep Venous Thrombosis · Pulmonary Embolus
Primary: Number of Participants With Venous Thromboembolism Events — 5; 0 Participants
Phase 4 N=32 Fondaparinux in Critically Ill Patients With Renal Failure
Venous Thromboembolism
Primary: To Determine if an Adjusted-dose of Fondaparinux 2.5 mg Subcutaneously (SQ) q48 hr in Critically Ill Patients With Renal Failure Will Achieve Peak and Trough Levels…
Phase 1 N=60 Safety and Pharmacokinetics Study of Redosing EXPAREL in Healthy Volunteers
Healthy Volunteers
Primary: Maximum Plasma Concentration (Cmax) — 129; 207; 202; 290 ng/mL
Phase 1 N=24 Effect of Low-Fat Food on Pexidartinib Pharmacokinetics in Healthy Volunteers
Healthy Volunteers
Primary: Maximum Observed Concentration in Plasma (Cmax) of Pexidartinib — 4580; 7090; 3870 ng/mL
Phase 1 N=8 A Clinical Study to Measure the Effect of OP-101 After Being Administered Subcutaneous in Healthy Volunteers
Healthy
Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events — 2; 3; 0; 0 Participants
Phase 1 N=12 A Study to Determine the Safety, Tolerability, and Pharmacokinetics of Lanadelumab Administered Intravenously in Healthy Adult Volunteer Participants
Healthy Volunteers
Primary: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) — 7; 2 Participants
N/A N=20 Enoxaparin Versus Aspirin in Patients With Cancer and Stroke
Cancer Patients First-ever Acute Ischemic Stroke
Primary: Safety Outcomes — 1; 0; 0; 3 Participants
Phase 1 N=64 Study to Evaluate the Safety, Tolerability, PK, and PD of PB2452 in Healthy Volunteers
Healthy
Primary: Number of Participants With Adverse Events (AEs) — 0; 0; 1; 1 Participants
Phase 1 N=14 A Study of a Single Dose of ALXN1210 in Healthy Participants
Healthy
Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 3; 4; 4 Participants